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Trial record 4 of 52380 for:    FOUND

Fasudil fOr redUcing elopemeNt and Spatial Disorientation (FOUND)

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ClinicalTrials.gov Identifier: NCT04793659
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Woolsey Pharmaceuticals

Brief Summary:

Fasudil, a Rho kinase inhibitor, is believed to reduce wandering behaviors of elopement and getting lost by improving spatial memory and navigation through improvements in hippocampal blood flow. Fasudil is non-sedating.

The aim of the study is to assess the effectiveness of oral fasudil in reducing wandering behaviors of elopement and/or getting lost in subjects with dementia. In addition, effects on wandering behaviors of excess movement and pacing, cognition, memory, neuropsychiatric symptomatology, caregiver/nursing staff burden, and the safety and tolerability of fasudil treatment will be assessed.


Condition or disease Intervention/treatment Phase
Dementia Drug: Oral Fasudil 90 mg/day Drug: Oral Fasudil 180 mg/day Drug: Oral Placebo Phase 2

Detailed Description:

The study population will consist of subjects with dementia and wandering behaviors of elopement and/or getting lost. While it is anticipated that most participants will be residing at home (with caregiver support), subjects may live in another setting such as a group home, an assisted living unit, or in a long-term care facility, provided that a caregiver, formal or informal, has sufficient contact with the subject to permit accurate completion of the necessary assessments.

Enrolled subjects will enter the Open-Label Phase and receive treatment with fasudil 90 mg/day (30 mg three times daily [tid]) for 6 weeks in Open-Label Period 1. Responders (i.e., subjects who improve 2 points or more on the GIW) will proceed to the Double-Blind Phase. Subjects in whom fasudil is well-tolerated (i.e. subjects with ≤ 2 drug-related AEs of mild intensity, no drug-related AEs of greater than mild intensity, and creatinine level of < 1.5 mg/dL at all times during the period) and who do not respond will enter Open-Label Period 2, and be dosed with fasudil 180 mg/day (60 mg tid) for 6 weeks. Responders will proceed to the Double-Blind Phase and non-responders will move to the final post-treatment visit. In the Double-Blind Phase, subjects will receive treatment with either placebo or the dose they responded to in the Open-Label Phase (90 mg/day or 180 mg/day) for 6 weeks (Double-Blind Period 1), following which treatment assignment will be crossed over for 6 weeks (Double-Blind Period 2). A final post-treatment visit will occur 14 days after the last dose of study drug. Visits may be performed by qualified healthcare professionals at home or other care setting, or at a doctor's office/clinic. Interviews may be performed by telephone and/or telemedicine as appropriate.

Study Endpoints:

Primary:

• The Global Impression of Wandering (GIW)

Secondary:

  • Weekly Wandering Report - Community Version (WWR-C)
  • The Revised Algase Wandering Scale - Community Version (RAWS-CV)
  • The Mini Mental State Examination (MMSE)
  • The Neuropsychiatric Inventory-Questionnaire (NPI-Q)
  • The Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
  • The Center for Neurological Study-Lability Scale (CNS-LS)
  • The Zarit Burden Interview (ZBI)
  • Safety
  • Tolerability

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Combined Open-Label and Double-Blind, Placebo-Controlled Crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Periods 1 and 2 of the open-label phase will be unblinded.

Periods 3 and 4 are double-blind crossover phases.

Primary Purpose: Treatment
Official Title: A Phase 2a Combined Open-Label and Double-Blind, Placebo-Controlled Crossover Study Assessing the Effectiveness, Safety, and Tolerability of Oral Fasudil in Subjects With Dementia and Wandering Behaviors of Elopement and/or Getting Lost
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Oral Fasudil 90 mg/day
Subjects will receive a daily dose of 90 mg Fasudil for 42 days (open-label period 1). After Period 1 is complete, if the subject is a responder to Fasudil 90 mg/day, they will be randomized to either Fasudil 90 mg/day or a placebo for 6 weeks (double-blind period 1), then crossover to the other arm for 6 weeks (double-blind period 2).
Drug: Oral Fasudil 90 mg/day
Oral tablet

Drug: Oral Placebo
Oral tablet

Experimental: Oral Fasudil 180 mg/day
If the subject is a not a responder in the open-label period 1 but tolerated Fasudil 90 mg/day, they will be escalated to Fasudil 180 mg/day (open-label period 2) for 42 days. If the subject is a responder to Fasudil 180 mg/day, they are randomized to either Fasudil 180 mg/day for 42 days or a placebo (double-blind period 1), then crossover to the other arm for 6 weeks (double-blind period 2).
Drug: Oral Fasudil 180 mg/day
Oral tablet

Drug: Oral Placebo
Oral tablet

Placebo Comparator: Oral Placebo
Placebo comparator arm to investigational drug (Fasudil 90 mg/day or 180 mg/day).
Drug: Oral Fasudil 90 mg/day
Oral tablet

Drug: Oral Fasudil 180 mg/day
Oral tablet

Drug: Oral Placebo
Oral tablet




Primary Outcome Measures :
  1. Change in Global Impression of Wandering (GIW) after oral Fasudil vs placebo in the Double-Blind Phase [ Time Frame: Week 6 and Week 12 of the Double-Blind period ]
    The GIW is a variant of the 7-point Clinical Global Impression-Severity (CGI-S) scale and is used in FOUND specifically to obtain the investigator's overall assessment of severity of the subject's wandering behavior.


Secondary Outcome Measures :
  1. Change in Weekly Wandering Report - Community Version (WWR-C) [ Time Frame: Weekly during the 12 weeks of the Double-Blind period ]
    The WWR-C is composed of targeted questions related to excess walking, spontaneous pacing, elopement, and wayfinding; it is designed to be assessed on a weekly basis by caregivers about subjects for whom they care. The WWR-C asks the caregiver to rate the subject's behavior for the previous week.

  2. Change in the Revised Algase Wandering Scale - Community Version (RAWS-CV) [ Time Frame: Week 6 and Week 12 of the Double-Blind period ]
    The RAWS-CV is a 40-item tool with 6 subscales to assess wandering behaviors (eloping behaviors, negative outcomes, mealtime impulsivity, persistent walking, repetitive walking, and spatial disorientation), and a total score scale.

  3. Change in Mini Mental State Examination (MMSE) [ Time Frame: Week 6 and Week 12 of the Double-Blind period ]
    The MMSE is a 30-point questionnaire that is used to measure cognitive impairment.

  4. Change in Neuropsychiatric Inventory-Questionnaire (NPI-Q) [ Time Frame: Week 6 and Week 12 of the Double-Blind period ]

    The NPI-Q provides an assessment of dementia-related emotional behavioral symptomatology in routine clinical practice settings. Caregiver distress is also assessed.

    The NPI-Q asks the assessor to rate the previous 30 days. At the Final Visit, the assessor will rate the NPI-Q for the 2-week period following the final dose. The scale is completed by the caregiver without input from the subject. All reasonable efforts should be made to ensure each NPI-Q for an individual subject is completed by the same caregiver to minimize inter-rater variability.


  5. Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) [ Time Frame: Week 6 and Week 12 of the Double-Blind period ]
    The CMAI-C is a 37-item scale to systematically assess agitation.

  6. Center for Neurological Study-Lability Scale (CNS-LS) [ Time Frame: Week 6 and Week 12 of the Double-Blind period ]
    The CNS-LS is a 7-item questionnaire to assess perceived frequency of pseudobulbar affect episodes.

  7. Zarit Burden Interview (ZBI) [ Time Frame: Week 6 and Week 12 of the Double-Blind period ]
    The ZBI is a 22-item scale to assess caregiver burden.

  8. Adverse Events (AEs) [ Time Frame: Through study completion, up to 26 weeks ]
  9. Serious Adverse Events (SAEs) [ Time Frame: Through study completion, up to 26 weeks ]
  10. Change in blood pressure [ Time Frame: Through study completion, up to 26 weeks ]
  11. Change in blood parameters [ Time Frame: Through study completion, up to 26 weeks ]
    Hematology: white blood cell count, hemoglobin, hematocrit, platelet count

  12. Change in blood chemistry [ Time Frame: Through study completion, up to 26 weeks ]
    Blood chemistry: glucose, sodium, potassium, bicarbonate, blood urea nitrogen, creatinine, cystatin c

  13. Change in liver function [ Time Frame: Through study completion, up to 26 weeks ]
    Liver function tests: albumin, total bilirubin, direct bilirubin, ALP, AST, ALT, gamma glutamyl transferase, lactate dehydrogenase

  14. Change in urine contents [ Time Frame: Through study completion, up to 26 weeks ]
    Urinalysis (occult blood, protein)

  15. Change in heart rhythm [ Time Frame: Through study completion, up to 26 weeks ]
    12-lead Electrocardiogram (ECG) will be used to obtain a record of cardiac activity

  16. Change in body weight [ Time Frame: Through study completion, up to 26 weeks ]
  17. Change in body temperature [ Time Frame: Through study completion, up to 26 weeks ]
  18. Change in respiratory rate [ Time Frame: Through study completion, up to 26 weeks ]
  19. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Through study completion, up to 26 weeks ]

    The C-SSRS is an assessment used to identify immediate risk of suicide, and is completed following the patient interview, review of medical record(s) and/or consultation with family members and/or other professionals. While the C-SSRS is a detailed interview, the full interview is needed only if the initial screening questions about suicidal ideation and behavior are positive.

    In subjects with severe cognitive impairment, i.e., so substantial as to interfere with an understanding of the concept of suicide, the C-SSRS may be omitted.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 to 90 years of age (inclusive).
  2. Diagnosis of dementia of any etiology.
  3. MMSE 9-24 (inclusive).
  4. Presence of one or both of the following wandering behaviors that in the opinion of the investigator, in consultation with caregiver, is at least of moderate severity (defined as clearly a wanderer, and this causes some distress or difficulty for both the subject and caregiver):

    1. Elopes or attempts to elope AND/OR
    2. Gets lost or is unable to locate a specific place.
  5. Independently ambulatory with or without assistive devices (such as canes or walkers). Subjects must not require assistance to transfer out of bed or a chair.
  6. Subject has a caregiver who has more than 10 hours/week of contact with the subject, is fluent and literate in English and is willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
  7. Consent obtained from the participant/legally authorized representative (LAR) in accordance with local regulations.

Exclusion Criteria:

  1. Expected change in medication that could interfere with the study or free movement of the subject.
  2. Serum creatinine ≥ 1.5 mg/dL.
  3. ALT and/or alkaline aminotransferase (AST) ≥ 2 X and/or alkaline phosphatase (ALP) ≥ 1.5 upper limit of normal.
  4. Blood pressure < 90/60.
  5. On more than one of the following drug classes: long-acting nitrates, beta-blockers, or calcium channel blockers.
  6. Any severe comorbidity that in the opinion of the Investigator would disallow safe participation in the trial.
  7. Women of child-bearing potential; females must be postmenopausal or surgically sterilized.
  8. Suicidal ideation per the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the opinion of the PI would pose a safety risk or interfere with the appropriate interpretation of study data.
  9. Planned change in the current living setting during the study.
  10. History within the last year of either two or more falls leading to clinically significant injuries or one or more fall leading to hospitalization, and/or evidence of orthostatic hypotension.
  11. Participation in another investigational drug study within 30 days before start of Open-Label period.
  12. Subjects who, in the opinion of the investigator, are not suitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793659


Contacts
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Contact: Ann Tunstall +1-703-981-8338 ann@woolseypharma.com
Contact: Ibrahim Mian, MD +1-336-671-5041 ibrahim@woolseypharma.com

Locations
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United States, Connecticut
New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
Contact: Nicole Jelic    203-914-1900    nicole@neinh.com   
Principal Investigator: Peter J. McAllister, MD         
United States, Florida
Accel Research Sites Recruiting
Lakeland, Florida, United States, 33803
Contact: Diana Holmes    863-940-2087    dholmes@accelclinical.com   
Principal Investigator: James Andersen, MD         
Lakes Research, LLC. Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Yami Sanchez    786-362-5763    ysanchez@lakesresearch.com   
Principal Investigator: Jose V. Perez, DO         
Accel Research Sites - Tampa Clinical Research Unit Recruiting
Tampa, Florida, United States, 33634
Contact: Gail McDonnell    813-877-8839    gmcdonnell@meridienresearch.net   
Principal Investigator: Deborah A. Burke, MD         
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
Contact: Dawn Arnone    732-244-2299    dawna@bbhnj.com   
Principal Investigator: Ashok K. Patel, MD         
United States, New Mexico
Albuquerque Neuroscience Inc. Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Anderson Riddle    505-848-3773    andy@albneuro.com   
Principal Investigator: Glenn M. Dempsey, MD         
United States, Texas
Clinical Trials of Texas, Inc. Recruiting
San Antonio, Texas, United States, 78229
Contact: Nathan Cortez    210-846-2164    ncortez@cttexas.com   
Principal Investigator: Martha E. Leatherman, MD         
United States, Virginia
Re:Cognition Health Recruiting
Fairfax, Virginia, United States, 22031
Contact: Monica Bland    703-520-9703    mbland@re-cognitionhealth.com   
Principal Investigator: Raymond S. Turner, MD         
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
Contact: David Elkins    757-446-5285    ElkinsDE@evms.edu   
Principal Investigator: Hamid Okhravi, MD         
Australia, South Australia
Modbury Hospital Recruiting
Modbury, South Australia, Australia, 5092
Contact: Greer Dymmott    08 7321 4248      
Principal Investigator: Sally Johns         
Australia, Victoria
Barwon Geriatrics Recruiting
Geelong, Victoria, Australia, 3220
Contact: Lea Del Rio    03 5223 1093      
Principal Investigator: Alaistar Mander         
GV Health Recruiting
Shepparton, Victoria, Australia, 3630
Contact: Ainsley Robinson    03 5832 3080      
Principal Investigator: Arup Bhattacharya         
Northeast Health Wangaratta Recruiting
Wangaratta, Victoria, Australia, 3677
Contact: Nicole Humphreys    03 5722 0111      
Principal Investigator: Lakshmi Dhakal         
Australia, Western Australia
Neurodegenerative Disorders Research Recruiting
West Perth, Western Australia, Australia, 6005
Contact: Cheryl MacFarlane    618-6317-9427      
Principal Investigator: PK Panegyres         
Sponsors and Collaborators
Woolsey Pharmaceuticals
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Responsible Party: Woolsey Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04793659    
Other Study ID Numbers: WP-0512-001
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Woolsey Pharmaceuticals:
Wandering Behavior
Dementia
Fasudil
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Fasudil
1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Protein Kinase Inhibitors
Enzyme Inhibitors